Apologies for incorporating a reply to you to a post from @otherperspective.That's ok.
You are correct, my believe that MSB will gain approval this time around is based on hope/wishful thinking perhaps.I'm inviting you to find that part of it if any that isn't based on just hope and wishful thinking.
The FDA is obliged as I understand it by law to have at least one adequate and well controlled trial to approve a biologics license application. Now I don't think anyone is going to say (in a legally compelling way) you didn't actually have at least on adequate and well controlled trial in front of you - if the FDA were say wrong or bribed and there was no proof of those things so effectively the FDA is itself the determiner of what constitutes at least one adequate and well controlled trial. But when they have spoken for themselves (as opposed to when MSB announcements have represented them - they have seemed to be logical and reasonable and consistent when they have spoken about MSB's BLA's.
I have read your posts amd re-read them after CRL#2 and I can't fault them, I agree with your logic (not that I could understand everything).
That adequate and well controlled trial threshold is a legislated requirement - sufficient data to clear that hurdle has to be available - can you see a way consistent with the facts to get MSB's BLA over that hurdle? If so that could be a way.
However, based on the comments and after 2 CRLs, making statements to the public and potential as well as existing customers including the most recent articles (if incorrect, Itescu could ask for a correction if he has been misquoted, as these comments are there for everyone to read and paint a picture of approval basically sorted), that leaves a lot of room for ambulance chasers - this time even more so than prior to CRL#1.The idea that CEOs or companies could correct things that are wrong that are favorably spun their way is put up all over hotcopper - it seems to go against the DNA of CEOs to unspin stuff that others have spun up for them.
If Silviu isn't asked were you quoted accurately - he doesn't have to deny it. If the reporter isn't asked did you quote Silviu accurately - the reporter doesn't have to deny it. But the January reference doesn't fit the timeline. Shareholders can ask - heck potential shareholders can ask - they just don't. If they did ask in multiples (2 or more) rather than as singles they wouldn't be able to be dismissed as being pests or nuts.
I also think that a CEO surely knows that it is time to step back after hitting the same brick wall head first three times.He is potentially fighting to save his life's work here. Possibly he'd be removed by a shareholder acquiring shares to actually take things over from him if he does fail again.
For that reason I believe that despite the points you have raised, the FDA and MSB are about to meet halfway.Nowhere in anything that you have written though do I see any reason at all for the FDA to abandon there previously thoroughly correct and scientifically valid position to meet halfway (its MSB that has failed not the FDA). Do you see anything that the FDA has done that ought be looking to make amends for in relation to MSB because I don't. If you do maybe I'd understand why you think the FDA should compromise on that requirement for at least one adequate and well controlled trial. They are not supposed to be passing products that aren't potent out of sympathy or as some sort of persistence award.
Your points about a meeting in March and positive feedback received shortly before the 27th March ASX announcement would coincide with the SP movements that occured just before the announcement:(picture).
Between the 7th of March and the 27th March Silviu's attitude changed greatly but there is no evidence except for what MSB has put in the public domain that the FDA have changed at all. And there is evidence in the patents and patent applications I have mentioned recently on the technical specifics of what MSB have been trying to get patented with respect to exactly the same two part matrix potency assay they have held all along - TNFR1 and ILR2alpha levels.
Its in those patent and patent applications that I am seeing how little MSB has - we could dig into those if you want.
I am however not chasing anyones rabbits. I am simply tired of the bating posts.If otherperspective makes a claim about a patent infringement and then doesn't back it up and then changes forum and directs his posts to others to avoid answering the simple question - what patent and what patent number are you referring to - and you help him when Truss20 did not - then yes you are helping him - you are not requiring him to answer the far more important issue he raised in the first place. His misbehavior in not substantiating a very important claim or withdrawing it will almost certainly be copied by others if you help him get away with it - like yeah say what you like, pay me a compliment and its all good.
That standard - substantiate big important claims or withdraw them has to be upheld or the forum will go even further down in terms of quality.
Whilst I was (and still am) trying to be more moderate with my replies, I will keep challenging the biased posts.Traders are inherently biased. Even if they are all holders on the same stock some of them will want to average down pumping to the other enthusiasts when they think there is a bit too much enthusiasm.
But the truth - facts - are not biased. That is why facts should be respected. That is why bold assertions without evidence should be asked for evidence. In the longer term companies can go all the way out of business if nit wit swing traders keep doubling down into bad management. Look at AVZ - they are no longer listed. The story is complicated - but there were plenty of warnings. The holders there are stuck with stock.
Holding shares in one company and posting on another, that alone doesn't make a person biased. Getting a bunch of options that go into the money at 29 cents probably makes a person biased. But it doesn't necessarily make them untruthful - whether what they say is truthful or factual depends on what they say and whether they can substantiate it.
BTW, if you consider yourself being biased towards (?) CYP, show me one post where that bias is showing. Just one, I dare you hahaI don't consider myself biased towards CYP.
Say you have a bias towards wanting MSB to get their BLA - that's fine - you've acknowledged that - I'm impartial in my opinion - I just require them to get over the threshold and don't think they have the data to do that. Show that they do, fault my reasoning and the MSB holders will applaud every point you can win against me in faulting my arguments and I want to know if my arguments are faulty and I can't get anyone much to dig into the research. If you do and you do it courteously you and I must teach each other - and those likely the positive to win will want you to win. You can be good cop. But it has to be about the data and about facts.
How can MSB possibly have at least one adequate and well controlled trial on the data they have provided? I say - they can't or at least I can't see any way they can without putting new batches of product into new patients.
(20min delay)